Skip to main content

This job has expired

Clinical Data Manager - Ger+Eng - South Germany

Employer
NonStop Consulting
Location
München (80335)
Salary
Negotiable
Closing date
Feb 14, 2019

View more

Sector
Science, Mathematics and Statistics
Contract Type
Employee
Hours
Full Time
Organization Type
Corporate
Jobseeker Type
Professional

Job Details

Clinical Data Manager - Ger+Eng - South Germany

One of our clients, an exciting biotech company is looking for a new person to come on board and join their team as Clinical Data Manager. This is a chance to work closely with the Clinical Affairs Team and support them with the collection and evaluation of the clinical data for Immune Analytics and Clinical Operations.

Using your experience in data management and daily data management tasks as well as to keep track of external data management activities will be part of your responsibilities. Further tasks include:
- Oversee and manage data management activities and provide support to sponsor / CRO clinical trial team members
- Oversee and manage the development, implementation and change management of clinical data management activities (i.e. data management plan, data validation plan, medical coding, data reconciliation, data listings, TLFs, medical data review, patient profiles, data cleaning)
- Oversee and manage the clinical data management systems (i.e. eCRF specification, edit check specification, eCRF completion guidelines, IRT specification, data transfer specifications, UAT plans, UAT performance)
- Ensure that CDISC standards are followed (SDTM/CDASH/ADAM)
- Oversee and manage clinical data transfers
- Participate in the definition and implementation of eCRF / IRT standards
- Review clinical trial documents (i.e. clinical trial protocols, and statistical analysis plan)
- Write Data Management SOPs
- Archive clinical trial databases and related documents

Who we are looking for:
- Advanced degree in Life Sciences (e.g. biology, chemistry, pharmaceuticals) or Computer Sciences or comparable experience
- At least 4-5 years of experience in data management in the pharmaceutical/biotechnology industry
- Experience with EDC and IRT systems
- CDISC (SDTM) expertise
- Experience in data management project management
- Expertise in SAS programming / R programming as well as knowledge of medical terminology, Coding, SAE reconciliation preferable
- Comprehensive knowledge of ICH-GCP, FDA and EMA regulations
- Fluent in English and German (both verbal and written)
- Good team player and communicator, with a positive attitude and a willingness to learn
- Track record of successful project leadership

Sounds interesting? Apply now and find out more!

#ClinicalDataManager #ClinicalAffairs #Munchen #Munich #ClinicalOperations

Company

Our Consultants are trained to deliver an exceptional standard of recruitment services to clients across the life sciences, chemical, care, educations, technical, digital and finance industries. 

Our clients – and bottom line profits - tell us that we do a great many things very well. Complacency, however, is the last word you would associate with us. We work incredibly hard to deliver better and better results, based on stronger and stronger service delivery.  Which is why we believe the best is yet to come – for us, our clients and for the people who have what it takes to join us on the journey.

The result? We’re expanding (in the UK and across Europe and even to Boston, US) and continue to post impressive performances in all our niche sectors. 

Company info
Website

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert